Associate Director, Study Management
1 week ago
With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza.
Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor.CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.
Could you be our next Associate Director of Study Management? The job is located in the King of Prussia office.
This is a hybrid position. You will report to the Director of CTS Study Management.The Opportunity:
You will develop the clinical supply operational strategy for an asset or program (a group of related, typically larger and more complex, clinical studies) throughout the multi-year lifecycle.
You will be responsible for clinical supply operational planning activities by influencing protocol design and using concepts like pooling to maximize reliability and efficiency across the asset or program.
You will also manage staff responsible for and lead, clinical supply activities such as kit design and blinding, forecasting demand of investigational product and ancillary supplies, establishing and managing the depot network and distribution to clinical sites, and ensuring final return and destruction for clinical studies within the asset/program and within budget.
The CTS Asset/Program Lead is a contributor to CTS strategy development, and sponsors/leads improvement programs for the clinical supply chain.
Responsibilities:
1. Establish and oversee the creation of multi-year clinical supply strategies and plans for an asset or program. Develop long-term clinical supply forecasts to support company planning processes.
Ensure agreement of these plans with the diverse Core Project Teams and Clinical Development Teams, and with Commercial, Operations and Global Supply Planning.2.
Influence protocol design and uses concepts like pooling, late stage customization, standardization and use-driven resupply across studies to maximize reliability and efficiency across the asset or program.
Develop proactive risk mitigation strategies and corrective action plans to address asset or program issues.3. Considers impact of asset or program clinical supply chain on sites and patients. Gather feedback and uses concepts (i.e. site to subject or direct to patient logistics) to improve patient and site experience.4. Represent CTS in Clinical Development Teams and Study Execution Teams. Review study protocols and provides clinical supply input. Determine clinical kit design based on protocol needs. Plan and forecasts product volume requirements for assigned global clinical programs based on clinical study assumptions. Adjust forecasts monthly based on study progress and changes to clinical and supply assumptions. Use simulation modeling capabilities to improve clinical supply plans and minimize the effect of inherent uncertainties.5.Establish global network of regional and local depots to distribute drug supplies and ancillary supplies to countries and sites in asset or program.
Manage compliant importation of drug supplies and ancillary supplies into regional and local depots. Establish cold chain management parameters for storage and distribution of drug supplies and ancillary supplies.6. Ensure development of clinical trial supply documentation and training to support study execution for clinical sites and patients (e.g. Investigational Medicinal Product Handling Manuals, product reconstitution videos).7. Ensure compliance of all clinical study activities with SOPs and regulations for assigned studies.8.Ensure creation and accuracy of budgets and forecasts including internal and external product costs, packaging and labeling costs, storage and distribution costs, and comparator and ancillary material costs across the asset or program.
Education & Requirements:
Bachelor's in life sciences, engineering, logistics or equivalent experience8 years' experience in biopharma R&D or supply chain including 5 years' experience in clinical trial supplies leading global studies; experience managing a teamBENEFITSMedical, Dental Vision401KPaid time Off#LI-HYBRIDOur BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1.
CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters.
Our benefits are designed to support the needs of our employees at every stage of their life.Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases.
Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
Learn more about CSL Behring.We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion.
Learn more about Diversity & Inclusion at CSL.Do work that matters at CSL Behring-
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